The Gardasil Problem: How The U.S. Lost Faith In A Promising Vaccine

Matthew Herper
,
Forbes Staff
I cover science and medicine, and believe this is biology's century.

Liquidia CEO Neal Fowler

This story appears in the April 23, 2012, issue of Forbes Magazine.

Neal Fowler, 50, the chief executive officer of a tiny biotech called ­Liquidia, was assuming a position common to road-warrior entrepreneurs: leaning his elbows on the seat-back tray in an airplane so he could gaze at the screen of his laptop. That’s when he felt the lump in his neck.

Fowler, a pharmacist, figured his lymph node was swollen by a recent cold, but the oncologist seated next to him—his chairman of the board—thought they’d better keep an eye on it.

The chairman was right. Over the next week the lymph node got bigger and harder. It was not sore to the touch, as happens during a cold. Fowler went to the doctor, then a specialist who knew exactly what he was seeing: a new form of throat cancer that ear, nose and throat specialists across the U.S. now say dominates their practices. Some 8,000 of these tonsil tumors turn up each year nationwide, courtesy of strain 16 of the human papilloma virus—the same sexually transmitted virus that causes cervical cancer. Usually transmitted when men perform oral sex on women, it can also spread through other forms of contact, perhaps even just kissing.

His prognosis was good—80% of those with this new tumor survive. His status as a drug industry veteran and chief executive of a biotechnology company didn’t hurt, either. He went from diagnosis to having the primary tumor removed from his tonsil in just a day. His first team of doctors wanted to do a second surgery, opening up his neck, but by polling other experts he found a ­different team and a different option: chemo­therapy and radiation.

But it gnaws at Fowler, who thinks about vaccines all day long—Liquidia’s vaccine work made it the only startup to receive an equity investment from the Bill & Melinda Gates Foundation—that one that might prevent other boys, including his teenagers, from ever developing this cancer isn’t being used. Gardasil, one of two HPV vaccines, is already approved in boys to prevent anal and penile cancers, but because these diseases are rare, only 1% actually get it. And tests that might well prove that this
Merck product can prevent the new throat cancer strain would take at least 20 years, until the boys sampled actually became sexually active and then contracted the disease.

“We’ve got this two- or three-decade window where more and more of these patients like myself are going to emerge,” says Fowler. “To me the ­[vaccine] risk is minimal, and I’d say, why not do that?”

The incidence of HPV throat cancer is rising

A big part of the answer is politics. Drug safety, vaccines, antibiotics and reproductive medicine—all have become proxies for the culture war, often tripping up public health in the process. Big Pharma hasn’t helped, with deep p.r. wounds that have made it anathema to both political parties. Nor has the FDA, which has shifted the goalposts on ­approving new antibiotics enough to scare away many innovators just as ­resistant bacteria have become a big health problem. Both parties undermined the FDA further by overruling it on how the Plan B emergency contraceptive should be used, weakening the agency’s authority. Now a coalition on the right is pushing to remove all testing of whether some medicines are ­effective, while many on the left still think the FDA ­remains too cozy with the drug industry.

“If you look at both sides of the political spectrum I’m amazed and appalled by the lack of knowledge that’s being put forward as knowledge,” says Robert Ruffolo, former head of research at Wyeth. “They’re not scientists, they’re not physicians, and many politicians will say almost anything during election season.”